WASHINGTON - On his second day in office as the first director of the HHS Office for Human Subject Protections (OHSP), Edward Greg Koski last week said the system for ensuring the safety of participants in clinical trials is seriously flawed, and that it must be revitalized and restructured with national standards and efforts to eradicate conflicts of interest.

Koski's remarks to a meeting of the National Bioethics Advisory Commission (NBAC) were in line with a commentary by his boss, Health and Human Services Secretary Donna Shalala, published last week in the New England Journal of Medicine.